Balneotherapy for chronic venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction or a combination of these symptoms, with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It places a large financial burden on health systems. There is a wide variety of treatment options for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) may be a relatively cheap and efficient way to deliver physiotherapy to people with CVI. This is an update of a review first published in 2019. OBJECTIVES: To assess the effectiveness and safety of balneotherapy for the treatment of people with chronic venous insufficiency. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 28 June 2022. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing balneotherapy to no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. disease severity, 2. health-related quality of life (HRQoL) and 3. ADVERSE EFFECTS: Our secondary outcomes were 1. pain, 2. oedema, 3. leg ulcer incidence and 4. skin pigmentation changes. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included nine randomised controlled trials involving 1126 participants with CVI. Seven studies evaluated balneotherapy versus no treatment, one study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis), and one study evaluated balneotherapy versus dryland exercises. We downgraded our certainty in the evidence due to a lack of blinding of participants and investigators, participant-reported outcomes and imprecision. Balneotherapy versus no treatment Balneotherapy compared to no treatment probably results in slightly improved disease severity signs and symptoms scores as assessed by the Venous Clinical Severity Score (VCSS; mean difference (MD) -1.75, 95% confidence interval (CI) -3.02 to -0.49; 3 studies, 671 participants; moderate-certainty evidence). Balneotherapy compared to no treatment may improve HRQoL as assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire 2 (CIVIQ2) at three months, but we are very uncertain about the results (MD -10.46, 95% CI -19.21 to -1.71; 2 studies, 153 participants; very low-certainty evidence). The intervention may improve HRQoL at 12 months (MD -4.48, 95% CI -8.61 to -0.36; 2 studies, 417 participants; low-certainty evidence). It is unclear if the intervention has an effect at six months (MD -2.99, 95% CI -6.53 to 0.56; 2 studies, 436 participants; low-certainty evidence) or nine months (MD -6.40, 95% CI -13.84 to 1.04; 1 study, 59 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the occurrence of adverse effects. The main adverse effects were thromboembolic events (odds radio (OR) 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; low-certainty evidence), erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; low-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study, 59 participants; low-certainty evidence). No studies reported any serious adverse effects. Balneotherapy compared with no treatment may improve pain scores slightly at three months (MD -1.12, 95% CI -1.35 to -0.88; 2 studies, 354 participants; low-certainty evidence); and six months (MD -1.02, 95% CI -1.25 to -0.78; 2 studies, 352 participants; low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on oedema (measured by leg circumference) at 24 days to three months, but we are very uncertain about the results (standardised mean difference (SMD) 0.32 cm, 95% CI -0.70 to 1.34; 3 studies, 369 participants; very low-certainty evidence). Balneotherapy compared with no treatment may have little or no effect on the incidence of leg ulcers at 12 months, but we are very uncertain about the results (OR 1.06, 95% CI 0.27 to 4.14; 2 studies, 449 participants; very low-certainty evidence). Balneotherapy compared with no treatment may slightly reduce skin pigmentation changes as measured by the pigmentation index at 12 months (MD -3.60, 95% CI -5.95 to -1.25; 1 study, 59 participants; low-certainty evidence). Balneotherapy versus melilotus officinalis For the comparison balneotherapy versus a phlebotonic drug (melilotus officinalis), there was little or no difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study, 35 participants; very low-certainty evidence) or oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study, 35 participants; very low-certainty evidence), but we are very uncertain about the results. The study reported no other outcomes of interest. Balneotherapy versus dryland exercise For the comparison balneotherapy versus dryland exercise, evidence from one study showed that balneotherapy may improve HRQoL as assessed by the Varicose Vein Symptom Questionnaire (VVSymQ), but we are very uncertain about the results (MD -3.00, 95% CI -3.80 to -2.20; 34 participants, very low-certainty evidence). Balneotherapy compared with dryland exercises may reduce oedema (leg volume) after five sessions of treatment (right leg: MD -840.70, 95% CI -1053.26 to -628.14; left leg: MD -767.50, 95% CI -910.07 to -624.93; 1 study, 34 participants, low-certainty evidence). The study reported no other outcomes of interest. AUTHORS' CONCLUSIONS: For the comparison balneotherapy versus no treatment, we identified moderate-certainty evidence that the intervention improves disease severity signs and symptoms scores slightly, low-certainty evidence that it improves pain and skin pigmentation changes, and very low-certainty evidence that it improves HRQoL. Balneotherapy compared with no treatment made little or no difference to adverse effects, oedema or incidence of leg ulcers. Evidence comparing balneotherapy with other interventions was very limited. To ensure adequate comparison between trials, future trials should standardise measurements of outcomes (e.g. disease severity signs and symptoms score, HRQoL, pain and oedema) and follow-up time points.

Balneotherapy for chronic venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a progressive and common disease that affects the superficial and deep venous systems of the lower limbs. CVI is characterised by valvular incompetence, reflux, venous obstruction, or a combination of these with consequent distal venous hypertension. Clinical manifestations of CVI include oedema, pain, skin changes, ulcerations and dilated skin veins in the lower limbs. It can result in a large financial burden on health systems. There is a wide variety of treatment options or therapies for CVI, ranging from surgery and medication to compression and physiotherapy. Balneotherapy (treatments involving water) is a relatively cheap option and potentially efficient way to deliver physical therapy for people with CVI. OBJECTIVES: To assess the efficacy and safety of balneotherapy for the treatment of people with chronic venous insufficiency (CVI). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the Clinical Trials.gov trials register to August 2018. We searched the LILACS and IBECS databases. We also checked references, searched citations and contacted study authors to identify additional studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing balneotherapy with no treatment or other types of treatment for CVI. We also included studies that used a combination of treatments. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed studies retrieved by the search strategies. Both review authors independently assessed selected studies for complete analysis. We resolved conflicts through discussion. We attempted to contact trial authors for missing data, obtaining additional information. For binary outcomes (leg ulcer incidence and adverse events), we presented the results using odds ratio (OR) with 95% confidence intervals (CI). For continuous outcomes (disease severity, health-related quality of life (HRQoL), pain, oedema, skin pigmentation), we presented the results as a mean difference (MD) with 95% CI. MAIN RESULTS: We included seven randomised controlled trials with 891 participants (outpatients in secondary care). We found no quasi-randomised controlled trials. Six studies (836 participants) evaluated balneotherapy versus no treatment. One study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis) (55 participants). There was a lack of blinding of participants and investigators, imprecision and inconsistency, which downgraded the certainty of the evidence.For the balneotherapy versus no treatment comparison, there probably was no improvement in favour of balneotherapy in disease severity signs and symptom score as assessed using the Venous Clinical Severity Score (VCSS) (MD -1.66, 95% CI -4.14 to 0.83; 2 studies, 484 participants; moderate-certainty evidence). Balneotherapy probably resulted in a moderate improvement in HRQoL as assessed by the Chronic Venous Insufficiency Questionnaire 2 (CVIQ2) at three months (MD -9.38, 95% CI -18.18 to -0.57; 2 studies, 149 participants; moderate-certainty evidence), nine months (MD -10.46, 95% CI -11.81 to -9.11; 1 study; 55 participants; moderate-certainty evidence), and 12 months (MD -4.99, 95% CI -9.19 to -0.78; 2 studies, 455 participants; moderate-certainty evidence). There was no clear difference in HRQoL between balneotherapy and no treatment at six months (MD -1.64, 95% CI -9.18 to 5.89; 2 studies, 445 participants; moderate-certainty evidence). Balneotherapy probably slightly improved pain compared with no treatment (MD -1.23, 95% CI -1.33 to -1.13; 1 study; 390 participants; moderate-certainty evidence). There was no clear effect related to oedema between the two groups at 24 days (MD 43.28 mL, 95% CI -102.74 to 189.30; 2 studies, 153 participants; very-low certainty evidence). There probably was no improvement in favour of balneotherapy in the incidence of leg ulcers (OR 1.69, 95% CI 0.82 to 3.48; 2 studies, 449 participants; moderate-certainty evidence). There was probably a reduction in incidence of skin pigmentation changes in favour of balneotherapy at 12 months (pigmentation index: MD -3.59, 95% CI -4.02 to -3.16; 1 study; 59 participants; low-certainty evidence). The main complications reported included erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; moderate-certainty evidence), thromboembolic events (OR 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; moderate-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study; 59 participants; low-certainty evidence), with no clear evidence of an increase in reported adverse effects with balneotherapy. There were no serious adverse events reported in any of the studies.For the balneotherapy versus a phlebotonic drug (melilotus officinalis) comparison, we observed no clear difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study; 35 participants; very low-certainty evidence) and oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study; 35 participants; very low-certainty evidence). This single study did not report on the other outcomes of interest. AUTHORS' CONCLUSIONS: We identified moderate- to low-certainty evidence that suggests that balneotherapy may result in a moderate improvement in pain, quality of life and skin pigmentation changes and has no clear effect on disease severity signs and symptoms score, adverse effects, leg ulcers and oedema when compared with no treatment. For future studies, measurements of outcomes such as disease severity sign and symptom score, quality of life, pain and oedema and choice of time points during follow-up must be standardised for adequate comparison between trials.

Confiabilidade intra e interexaminador da análise por padrões de impressão de plantigrafias de pessoas diabéticas obtidas com o Harris Mat / Inter- and intra-examiner reliability of footprint pattern analysis obtained from diabetics using the Harris Mat

INTRODUÇÃO: A hiperpressão plantar é um fator de risco comprovado para a ulceração em portadores de diabetes mellitus. O "Harris and Beath Footprinting Mat" é um dos instrumentos usados nas avaliações para rastreamento do risco de ulceração nos pés desses pacientes. Não há relatos na literatura sobre estudos da confiabilidade da análise das impressões plantares usando o critério de padrões de impressão. OBJETIVO: O objetivo deste estudo foi avaliar a confiabilidade inter e intraexaminador da análise dos padrões de impressão plantar obtida com o "Harris and Beath Footprinting Mat". MÉTODOS: As impressões plantares de 41 sujeitos foram obtidas usando o plantígrafo. As imagens foram submetidas à análise de três examinadores independentes. Para verificar a confiabilidade intraexaminador, um dos examinadores repetiu a análise após uma semana. RESULTADOS: O coeficiente de Kappa ponderado foi excelente (Kp>0,80) para as análises inter e intraexaminador para a maioria dos pontos estudados em ambos os pés. CONCLUSÃO: O critério de análise por padrões de impressão plantar obtidas com o "Harris and Beath Footprinting Mat" apresentou boa confiabilidade e de alta a excelente concordância para as condições inter e intraexaminador. Esse método é confiável para análises que envolvam um ou mais examinadores.

INTRODUCTION: High plantar pressure is a proven risk factor for ulceration among individuals with diabetes mellitus. The Harris and Beath footprinting mat is one of the tools used in screening for foot ulceration risk among these subjects. There are no reports in the literature on the reliability of footprint analysis using print pattern criteria. OBJECTIVE: The aim of this study was to evaluate the inter- and intra-examiner reliability of the analysis of footprint patterns obtained using the Harris and Beath footprinting mat. METHODS: Footprints were taken from 41 subjects using the footprinting mat. The images were subjected to analysis by three independent examiners. To investigate the intra-examiner reliability, the analysis was repeated by one of the examiners one week later. RESULTS: The weighted kappa coefficient was excellent (Kw>0.80) for the inter- and intra-examiner analyses for most of the points studied on both feet. CONCLUSIONS: The criteria for analyzing footprint patterns obtained using the Harris and Beath footprinting mat presented good reliability and high to excellent inter- and intra-examiner agreement. This method is reliable for analyses involving one or more examiners.

[Evaluation of a neuropathic ulcers prevention program for patients with diabetes]. / Avaliação de um programa para prevenção de úlceras neuropáticas em portadores de diabetes.

BACKGROUND: Neuropathic foot ulcers are among the major health problems faced by patients with diabetes mellitus. OBJECTIVE: To evaluate the preventive efficacy of a therapeutic education and protective footwear program in the incidence and recurrence of neuropathic ulcers due to diabetes. METHODS: Fifty-three patients with diabetes and neuropathy from a public healthcare unit in Porto Alegre, Rio Grande do Sul, took part in a clinical trial for two years. The participants were randomly allocated to an intervention group (n=30) or a control group (n=23). Therapeutic education was provided in group sessions, and protective footwear was supplied in accordance with individual prescriptions. The nonparametric Mann-Whitney test was used to determine differences in incidence and recurrence of ulceration between the groups. Life-table analysis and the Kaplan-Meier method were used to measure the duration of ulcer-free survival. RESULTS: In the intervention group, the ulcer incidence rate was 38.1% compared to 51.1% in the control group. Among the participants who presented ulcers, 83% were in the control group and 16.7% in the intervention group. After one year, the participants in the intervention group had a 75% chance of being ulcer-free, compared with 61% in the control group, and these percentages reduced to 60% and 52% respectively after two years. There was a tendency toward shorter survival among the control group participants. CONCLUSION: Although the proposed program lowered recurrence rates and increased the duration of ulcer-free survival, it was unable to prevent occurrence and recurrence of neuropathic ulcers due to diabetes.

Avaliação de um programa para prevenção de úlceras neuropáticas em portadores de diabetes / Evaluation of a neuropathic ulcers prevention program for patients with diabetes

CONTEXTUALIZAÇÃO: Úlceras neuropáticas nos pés são um dos grandes problemas de saúde enfrentados por portadores de diabetes mellitus. OBJETIVO: Avaliar a eficácia preventiva de programa de educação terapêutica e de calçados para proteção dos pés quanto à incidência e recorrência de úlceras neuropáticas por diabetes. MÉTODOS: Um total de 53 pacientes de uma unidade de saúde pública de Porto Alegre/RS, portadores de diabetes e neuropatia, participaram de um ensaio clínico durante dois anos. Os sujeitos foram alocados aleatoriamente em grupo de intervenção (GI) (n=30) ou controle (GC) (n=23). A educação terapêutica foi realizada em grupo, e o calçado para proteção fornecido conforme prescrição individual. Utilizou-se o teste não paramétrico de Mann Whitney para determinar a diferença de incidência e recorrência de ulceração entre os grupos. A análise da tábua de vida e o método de Kaplan-Meier foram usados para medir o tempo de sobrevida sem úlcera. RESULTADOS: A incidência de lesão no GI foi de 38,1 por cento versus 57,1 por cento no GC. Dos sujeitos que apresentaram úlcera, 83 por cento pertenciam ao GC e 16,7 por cento ao GI. Em um ano, os participantes do GI o mostraram 75 por cento de probabilidade de se encontrarem sem lesão, contra 61 por cento do GC, reduzindo para 60 por cento e 52 por cento, respectivamente, em dois anos. Há uma tendência de menor sobrevida em participantes do GC. CONCLUSÃO: Embora com índices menores de recorrência e maior sobrevida sem lesão, o programa proposto não foi capaz de prevenir a ocorrência e recorrência de úlceras neuropáticas por diabetes.

BACKGROUND: Neuropathic foot ulcers are among the major health problems faced by patients with diabetes mellitus. OBJECTIVE: To evaluate the preventive efficacy of a therapeutic education and protective footwear program in the incidence and recurrence of neuropathic ulcers due to diabetes. METHODS: Fifty-three patients with diabetes and neuropathy from a public healthcare unit in Porto Alegre, Rio Grande do Sul, took part in a clinical trial for two years. The participants were randomly allocated to an intervention group (n=30) or a control group (n=23). Therapeutic education was provided in group sessions, and protective footwear was supplied in accordance with individual prescriptions. The nonparametric Mann-Whitney test was used to determine differences in incidence and recurrence of ulceration between the groups. Life-table analysis and the Kaplan-Meier method were used to measure the duration of ulcer-free survival. RESULTS: In the intervention group, the ulcer incidence rate was 38.1 percent compared to 51.1 percent in the control group. Among the participants who presented ulcers, 83 percent were in the control group and 16.7 percent in the intervention group. After one year, the participants in the intervention group had a 75 percent chance of being ulcer-free, compared with 61 percent in the control group, and these percentages reduced to 60 percent and 52 percent respectively after two years. There was a tendency toward shorter survival among the control group participants. CONCLUSION: Although the proposed program lowered recurrence rates and increased the duration of ulcer-free survival, it was unable to prevent occurrence and recurrence of neuropathic ulcers due to diabetes.